MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM ASD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number	ASD32A
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the gore® cardioform asd occluder instruction for use, in the section "potential device ¿ or procedure-related adverse events".Adverse events associated with the use of the occluder may include, but are not limited to: device embolism.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 cfr part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
It was reported; the physician selected a 32mm gore® cardioform asd occluder to close an atrial septal defect.The device crossed the defect on a guidewire and was placed in the defect with minimal shunt.After locking, the shunt was more pronounced, and the physician decided to remove the device for upsizing.The physician felt tension while trying to recapture the device with the retrieval cord.The device was pulled down to the inferior vena cava to aid in recapture.As more pressure was applied, the retrieval cord broke and the device embolized.The embolized occluder was removed with a snare from the right iliac vein.On inspection, the tip of the delivery catheter was kinked at the guidewire port.A 37mm gore® cardioform asd occluder was implanted with no issues.The patient was doing well following the procedure.
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The evaluation of the returned device showed the following: the control shuttle was in the fully deployed position.The lock release shuttle was in an approximately half deployed position and the inner handle components indicated a locked state.Two distinct pieces of the retrieval cord were identified, with two of the three ends being frayed.The delivery catheter was damaged near the guidewire port.The retrieval loop did not appear to have any breaks or sharp edges.The occluder and lock loop were normal in size and shape.The physician¿s complaint of the retrieval cord breaking could be confirmed; however, the tension the physician observed during recapture could not be confirmed through the evaluation.The physician¿s complaint of the delivery catheter being damaged near the guidewire port could also be confirmed through the evaluation.Due to the returned state of the device, a root cause for the complaint was unable to be determined.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24872382
• Report Number: 2017233-2026-07368
• Device Sequence Number: 15957502
• Product Code: MLV
• UDI-Device Identifier: 00733132636495
• UDI-Public: (01)00733132636495(17)281021
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ASD32A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female